Cannabinoid and menthol gel compositions, patches and methods

ABSTRACT

The present disclosure relates to compositions methods of use and methods of manufacturing, hydrous hydrogel compositions useful as topical oral analgesics including cannabinoids and menthol.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to and the benefit of U.S. ProvisionalPatent Application Ser. No. 62/726,713 filed Sep. 4, 2018 and U.S.patent application Ser. No. 16/419,336 filed May 22, 2019, thedisclosures of which is incorporated herein by reference in itsentirety.

FIELD

The aspects of the present disclosure relate to gel compositionsincluding active agents such as cannabinoids and menthol.

BACKGROUND

There is a need for novel treatments for pain and inflammation onvarious parts of the body. Some current agents may be ineffective andcan, for example, come with unacceptable side effects. Furthermore,there is a growing concern about the overuse of opioid pain treatments.

Hydrogels can be used as a vehicle for the delivery of drugs and othertherapeutically active agents. They refer to a network of hydrophilicpolymer chains that are generally found as a colloidal gel in whichwater is the dispersion medium. Hydrogels are highly absorbent (they cancontain over 99.9% water) natural or synthetic polymers and can alsopossess a degree of flexibility very similar to natural tissue, due totheir significant water content (“Terminology of polymers andpolymerization processes in dispersed systems (IUPAC Recommendations2011)”. Pure and Applied Chemistry 83 (12): 2229-2259. 2011).

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings illustrate presently preferred embodiments ofthe present disclosure, and together with the general description givenabove and the detailed description given below, serve to explain theprinciples of the present disclosure.

FIG. 1 is a perspective view of an embodiment of the present disclosure;

FIGS. 2A and 2B are perspective views of other embodiments of thepresent disclosure;

FIGS. 3A to 3F illustrate an exemplary implementation of the aspects ofthe disclosed embodiments; and

FIGS. 4A and 4B illustrate perspective and cross-sectional views of anexemplary packaging embodiment of the present disclosure.

SUMMARY

These and other aspects and advantages of the exemplary embodiments willbecome apparent from the detailed description. Additional aspects andadvantages of the present disclosure will be set forth in thedescription that follows, and in part will be obvious from thedescription, or may be learned by practice of the present disclosure.Moreover, the aspects and advantages of the present disclosure may berealized and obtained by means of the instrumentalities and combinationsparticularly pointed out in the appended claims.

In one embodiment, a transdermal analgesic hydrogel device is provided.The transdermal analgesic hydrogel device includes a surface to beapplied to the skin of a mammal, the surface having an area ranging insize from about 9 cm² to about 256 cm²; water in an amount of from about70 wt % to about 95 wt %; a biocompatible polymer in an amount of fromabout 0.5 wt % to about 5 wt %; a polyalcohol in an amount of from about1 wt % to about 5 wt %; at least one cannabinoid is in an amount of fromabout 0.1 wt % to about 10 wt %.; and menthol is in an amount of fromabout 1 wt % to about 10 wt %.

In another embodiment, a transdermal analgesic hydrogel patch fortopical application to the skin of a mammal is provided. The transdermalanalgesic hydrogel patch includes water in an amount of from about 70 wt% to about 95 wt %; carageenan in an amount of from about 0.5 wt % toabout 5 wt %; glycerin in an amount of from about 1 wt % to about 5 wt%; full spectrum hemp oil in an amount of from about 0.1 wt % to about10 wt %.; and menthol in an amount of from about 1 wt % to about 10 wt%.

In another embodiment, a method of treating pain or inflammation in abody part or portion thereof of a mammal using a transdermal hydrogelpatch is provided. The transdermal hydrogel patch including a unit doseformulation including water in an amount of from about 70 wt % to about95 wt %; carageenan in an amount of from about 0.5 wt % to about 5 wt %;glycerin in an amount of from about 1 wt % to about 5 wt %; fullspectrum hemp oil in a unit dose amount of from about 2 mg. to about 195mg; and menthol in a unit dose amount of from about 2 mg. to about 400mg. The method includes administering the transdermal hydrogel patch toa body part of the mammal.

DETAILED DESCRIPTION

Various embodiments are described hereinafter. It should be noted thatthe specific embodiments are not intended as an exhaustive descriptionor as a limitation to the broader aspects discussed herein. One aspectdescribed in conjunction with a particular embodiment is not necessarilylimited to that embodiment and can be practiced with any otherembodiment(s).

The use of the terms “a” and “an” and “the” and similar referents in thecontext of describing the elements (especially in the context of thefollowing claims) are to be construed to cover both the singular and theplural, unless otherwise indicated herein or clearly contradicted bycontext. Recitation of ranges of values herein are merely intended toserve as a shorthand method of referring individually to each separatevalue falling within the range, unless otherwise indicated herein, andeach separate value is incorporated into the specification as if it wereindividually recited herein. All methods described herein can beperformed in any suitable order unless otherwise indicated herein orotherwise clearly contradicted by context. The use of any and allexamples, or exemplary language (e.g., “such as”) provided herein, isintended merely to better illuminate the embodiments and does not pose alimitation on the scope of the claims unless otherwise stated. Nolanguage in the specification should be construed as indicating anynon-claimed element as essential.

Unless otherwise indicated, all numbers expressing quantities ofingredients, reaction conditions, and so forth used in the specificationand claims are to be understood as being modified in all instances bythe term “about.” Accordingly, unless indicated to the contrary, thenumerical parameters set forth in this specification and attached claimsare approximations that may vary depending upon the desired propertiessought to be obtained by embodiments of the present disclosure. As usedherein, “about” may be understood by persons of ordinary skill in theart and can vary to some extent depending upon the context in which itis used. If there are uses of the term which are not clear to persons ofordinary skill in the art, given the context in which it is used,“about” may mean up to plus or minus 10% of the particular term.

The terms “%”, “% by weight”, “weight %” and “wt %” are all intended tomean unless otherwise stated, percents by weight based upon a totalweight of 100% end composition weight. Thus 10% by weight means that thecomponent constitutes 10 wt. parts out of every 100 wt. parts of totalcomposition.

The term “pharmaceutically acceptable” means that which is useful inpreparing a pharmaceutical composition that is generally non-toxic andis not biologically undesirable and includes that which is acceptablefor veterinary use and/or human pharmaceutical use.

The term “topically acceptable” means the compound, substance or devicemay be administered to or onto the surface of a patient, including theskin or other accessible tissues, without substantial harmful effects tothe body part and/or its surfaces.

The aspects of the present disclosure relate to compositions includinghydrous hydrogel compositions and hydrous hydrogel composition patchesfor the delivery of an active agent(s). The aspects of the presentdisclosure also relate to processes for the preparation of,intermediates used in the preparation of, compositions (e.g.,pharmaceutical, medical device cosmetic, industrial) containing and theuses of such hydrous hydrogels in the treatment of disorders orapplication of specified agents to a skin surface.

One specific embodiment of the present disclosure relates tocompositions comprising an active agent (including acceptable saltthereof) pharmaceutical composition. Accordingly, in one embodiment, thepresent disclosure relates to a pharmaceutical composition comprising anactive agent, a pharmaceutically acceptable carrier and, optionally,additional medicinal or pharmaceutical agent(s).

Active agents include pharmaceutical agents such as analgesics,decongestants, bronchodilators and other antiasthmatic agents,cardiovascular agents such as beta-blockers, ACE inhibitors, diuretics,antithrombics, etc., diabetic agents, antihistamines, anesthetics,antifungals, antinauseants, antiemetics, antibacterial agents,antifungal agents, corticosteroids, neurological agents,anti-inflammatories, vaccines, biological agents (such as Humera, Enbreland Remicade), wound healing agents and anticonvulsants. Vitamins(particularly A, C, D and E) are a particular embodiment of an activeagent. The concentration of the active ingredient in the gel base is, ofcourse, dependent on the identity of the active agent, the condition andpatient being treated and the potency desired.

The formulations of the present disclosure are also useful in the fieldsof human medicine for the administration of active agents to people(i.e., human patients) and veterinary medicine for the administration ofactive agents to pets and farm animals.

The aspects of the present disclosure relate to compositions used torelieve pain (i.e., analgesics) and/or inflammation, methods of makingsuch compositions and methods of using such compositions includingtopically applied (e.g., to skin or another body part) compositionsincluding pharmaceutical compositions, including analgesic and/oranti-inflammatory pharmaceutical compositions for the treatment of painand/or inflammation, that contain a pharmaceutically effective amount ofa pharmaceutically acceptable and effective cannabinoid, menthol and apharmaceutically acceptable carrier, such as for example, a hydroushydrogel material, vehicle or carrier. Such compositions may alsoinclude, for example, analgesic and/or anti-inflammatory pharmaceuticalcompositions for the treatment of pain and/or inflammation that containa pharmaceutically effective amount of a pharmaceutically acceptable andeffective cannabinoid, menthol and a pharmaceutically acceptablecarrier, such as for example, a hydrous hydrogel material, material orcarrier.

The combination of cannabinoid and menthol into a single therapeuticcomposition, for example, a hydrous hydrogel vehicle, can provideimproved and better focused delivery of the actives to a patient thanseparately applying the cannabinoid and menthol separately (to differentareas of the body or layered one on top of another) without the hydroushydrogel vehicle.

Pharmaceutical compositions, such as, for example, embodiments of thepresent disclosure, include products and compositions, for example,hydrous hydrogel products and compositions (e.g., patches includinghydrous gel patches and hydrous hydrogel patches) including products ofa mass of hydrogel composition in a desired size, shape and weightwhich, in the ordinary course of usage, can be placed topically on abody part (e.g., arm, leg, knee, torso, head, neck, foot as well asthose parts that make-up them) for purposes of local and/or systemicadministration of particular therapeutic agents for a time sufficient tobe effective for purposes of therapeutic activity to the body part andtissues thereof or other tissues remote from the application site inorder to provide relief from the malady being suffered (e.g., painrelief though an analgesic and/or anesthetic effect) including a maladyof the body part (e.g., pain and/or inflammation) to which the productsand compositions of the present disclosure can be directly applied forrelief. After being present in contact with the body part for a timesufficient to be effective for purposes of therapeutic activity, theycan be removed from the body part. Such application to the body partincludes placing the pharmaceutical composition in contact with the skincovering the body part.

Embodiments of the present disclosure may be delivered for local orsystemic administration to a body part of a person to be treated withthe embodiment, for example, a body or skin surface thereof by placingan embodiment of the present disclosure on a body part or skin surfacethereof, for example, a knee, leg, back of hand, arm, lower back-upperback, shoulder and forehead, in active agent-transmitting relationthereto, the active agents being cannabinoid, for example, aphytocannabinoid or full spectrum hemp oil, and menthol. Alternatively,an embodiment of the present disclosure may be incorporated into adelivery system, such as a unit dose delivery system or device (e.g. a“patch.””). The delivery system, device or “patch” can be of a suitablesize and shape to fit against a body part so as to be applied to theskin surface thereof. A suitable size, for example, is illustrated inFIG. 1 which can include the shape of a square or rectangle 100 or otherpolygon shape (including, e.g., triangle, pentagon, hexagon, etc.) withsurface areas 102 and 104 (on opposing sides) and the dimensions ofsides 106, 107, 110 and 112, each ranging in length 114, 116, 118 and120, respectively ranging from about 3 cm to about 16 cm including eachsurface area ranging from about 9 cm² to about 256 cm², about 4.2 cm toabout 6.5 cm including each surface area ranging from about 18 cm² toabout 42 cm², about 10 cm to about 14 cm including each surface arearanging from about 100 cm² to about 196 cm² and about 12 cm to about 16cm including each surface area ranging from about 144 cm² to about 256cm². For example, embodiments could include patches with sides 106, 107,110 and 112, each ranging in length 114, 116, 118 and 120, respectively,that are about 6.5 cm.×about 4.2 cm (surface area about 27.3 cm²), about10 cm×about 14 cm (surface area about 140 cm²) and about 12 cm×about 16cm (surface area about 192 cm²).

Thickness 122 can range from about 0.05 cm to about 0.5 cm, about 0.05cm to about 0.1 cm, about 0.05 cm to about 0.07 cm, about 0.0508 toabout 0.06604 cm. Volumes of the patches can range from about 0.45 ml toabout 128 ml, about 0.45 ml to about 25.6 ml, about 0.45 ml to about 18ml, about 0.4572 ml. to about 17 ml, in keeping with the above patchdimensions. For example, the above referenced embodiments that includepatches with a surface area 27.3 cm² based on the above ranges ofthickness could have volumes ranging from about 1.4 ml to about 13.7 ml,about 1.4 ml to about 2.73 ml, 1.4 ml to about 1.9 ml, about 1.386 ml toabout 1.803 ml; a surface area 140 cm² based on the above ranges ofthickness could have volumes ranging from about 7 ml to about 70 ml,about 7 ml to about 14 ml, 7 ml to about 9.8 ml, about 7.112 ml to about9.296 ml; and a surface area 192 cm² based on the above ranges ofthickness could have volumes ranging from about 9.6 ml to about 96 ml,about 9.6 ml to about 19.2 ml, 9.6 ml to about 13.4 ml, about 0.754 mlto about 12.680 ml.

In the embodiment of illustrated in FIG. 1 a square would have sides105, 107, 110 and 112 approximately equal in dimensions while arectangle would have sides 106 and 110 approximately equal in dimensionsalong with sides 107 and 112 approximately equal, but the dimensions ofsides 106 and 110 may not always be equal to the dimension of sides 107and 112. In other embodiments, the dimensions of any one of sides 106,107, 110 and 112 may be equal to the dimensions of the other sides.

Other embodiment shapes can also include a circle 200 illustrated inFIG. 2A having a generally circular shape with surface areas 202 and 204on opposing sides thereof or an ellipse 206 illustrated in FIG. 2B andwith surface areas 208 and 210 on opposing sides thereof. Diameter 212for FIG. 2A and diameter 214 for FIG. 2B can range from about 3 cm toabout 16 cm including each surface area ranging from about 7 cm² toabout 201 cm², a diameter ranging from about 4.2 cm to about 6.5 cmincluding each surface area ranging from about 14 cm² to about 33 cm², adiameter ranging from about 10 cm to about 14 cm including each surfacearea ranging from about 78 cm² to about 154 cm² and a diameter rangingfrom about 12 cm to about 16 cm including each surface area ranging fromabout 113 cm² to about 201 cm²

The thickness 216 in circle 200 in FIG. 2A and thickness 218 ellipse 206in FIG. 2B can range from about 0.05 cm to about 0.5 cm, about 0.05 cmto about 0.1 cm, about 0.05 cm to about 0.07 cm, about 0.0508 to about0.06604 cm.

Embodiments of the present disclosure are intended to be placed on theskin surface of a body part or body parts or portions thereof where aperson is experiencing pain and/or inflammation resulting from, forexample, injury or other physical diseases, stresses or conditions.Non-limiting exemplary embodiments showing possible placement areillustrated in FIGS. 3A to 3F. FIGS. 3A and 3B show a top view and sideview, respectively, of an arm 300 including a hand 302, wrist 304,forearm 306, elbow area 307 and upper arm 308. One of the embodiments ofthe present disclosure 310 can be positioned against the hand 302 at312. An alternative is an embodiment of the present disclosure 314 canbe positioned against the wrist 304 at 316. An alternative is anembodiment of the present disclosure 318 can be positioned against theforearm 306 at 320. An alternative is an embodiment of the presentdisclosure 319 can be positioned against the lower part of the forearm306 at 321. An alternative is an embodiment of the present disclosure322 can be positioned against the elbow area 307 at 324. An alternativeis an embodiment of the present disclosure 326 can be positioned againstthe upper arm 308 at 328.

FIGS. 3C and 3D show a side view and front view, respectively, of a leg330 including a foot 332, ankle area 334, calf 336, knee area 338 andupper leg 340. One of the embodiments of the present disclosure 342 canbe positioned against the front of the ankle area 334 at 344. Analternative is an embodiment of the present disclosure 346 can bepositioned against the side of the ankle area 334 at 348. An alternativeis an embodiment of the present disclosure 350 can be positioned againstthe back of the ankle area 334 (e.g. against the Achilles tendon) at352. An alternative is an embodiment of the present disclosure 354 canbe positioned against the side of the back of the calf 336 at 356. Analternative is an embodiment of the present disclosure 358 can bepositioned against the knee area 338 at 360. An alternative is anembodiment of the present disclosure 362 can be positioned against thefront of the upper leg 340 at 364.

FIG. 3E shows a rear view of an upper torso 368 including back 370, arms372, shoulder area 374, spinal/backbone area 376 and neck 378. One ofthe embodiments of the present disclosure 380 can be positioned againstthe lower region of the back 370 adjacent the spinal/backbone area 376at 382. An alternative is an embodiment of the present disclosure 384can be positioned against the upper region of the back 370 adjacent thespinal/backbone area 376 at 386. An alternative is an embodiment of thepresent disclosure 388 can be positioned against the back of the neck378 (e.g. against the spinal/backbone area 376) at 390. An alternativeis an embodiment of the present disclosure 391 can be positioned againstthe upper area of the shoulder area 374 at 392. An alternative is anembodiment of the present disclosure 393 can be positioned against thelower area of the shoulder area 374 at 394.

FIG. 3F shows a front view of a head 395 including a forehead 396. Oneof the embodiments of the present disclosure 397 can be positionedagainst the forehead 396 at 398.

Although all surfaces of the embodiments of the present disclosure canbe applied to the skin surface of body parts or portions thereof toadminister the agents included therein (e.g., CBD and menthol) fortransdermal delivery into and through the tissues of the skin surface tobring about the intended local and/or systemic effect, the largestsurfaces (e.g., surface areas 102 and 104 in FIG. 1, in FIG. 2A withsurface areas 202 and 204 and in FIG. 2B and with surface areas 208 and210) should preferably be placed against those skin surfaces includingthe embodiments of FIGS. 3A to 3F.

Non-limiting examples of injuries or other physical diseases orconditions causing pain and/or inflammation for which embodiments of thepresent disclosure can be used to reduce or lessen the pain and/orinflammation can include arthritis conditions (e.g., osteo, rheumatoid,psoriatic, fibromyalgia, etc.), head pain (e.g., concussion, head ache,migraine), orthopedic injuries or conditions (e.g., bone fracture orbreak; dislocated joint or bone; torn, stressed or strained ligament ortendon; bruising or trauma to tissue; back or spinal pain or herniateddisc; tendonitis; gout, bursitis), muscles aches and pains (e.g., fromstress and physical exertion) and post-surgery recovery (e.g., recoveryfrom orthopedic surgery to repair a broken bone, back condition such asherniated disk or torn ligament, orthoscopic surgery.

The hydrogel compositions of the present disclosure may also include anadhesive composition on one side thereof (e.g., one of the surface areasof the above embodiments). In manufacturing such systems of anembodiment, the hydrogel adhesive composition may be cast or extrudedonto a backing layer or release liner and once the backing layer orrelease liner is removed will serve as the skin-contacting face of thesystem and act as an active agent reservoir. Alternatively, the hydrogelcomposition may be used as an active agent reservoir within the interiorof such a system, with a conventional skin adhesive laminated thereto toaffix the system to a surface of the body part of a patient, the bodypart that is experiencing pain and/or inflammation. In such embodimentsincluding a reservoir, the cannabinoid, for example, full spectrum hempoil, could be in the reservoir and the menthol in the hydrogel housingthe reservoir, where each reservoir for the full spectrum hemp oil andmenthol is the same or different.

Cannabinoids are an active agent and a class of chemical compounds thatcan be derived from plants (phytocannabinoids) or syntheticallyproduced. Cannabinoids can have local and systemic analgesic, painrelieving, pain treating and anti-inflammatory therapeutic properties.Cannabinoids may also have other medical benefits and/or be useful intreating other medical conditions including, for example, reduction ofanxiety and depression, reduction of symptoms like nausea, vomiting andpain related to cancer treatments, reduction of acne, protection of theneural system and benefits for the heart and circulatory system by thelowering of blood pressure. Cannabinoids can also have therapeutic valueas a nutrient and can be included in composition and method embodimentsof the present disclosure in an effective amount to perform thatfunction.

Examples of phytocannabinoids include Cannabidiol (CBD) including, forexample, CBD oil, Cannabinol (CBN) and tetrahydrocannabinol (THC), thelatter being a known psychotropic compound and the first two beingnon-psychotropic. Cannabis and hemp plants can exhibit wide variation inthe quantity and type of cannabinoids they produce. Selective breedingof the plants can be used to control the genetics of plants and modifythe cannabinoids produced by the plant. For example, there are strainsthat are used as fiber (commonly called hemp) and, as a result, havebeen bred such that they are low in psychoactive chemicals like THC.Such strains (e.g., hemp) used in medicine are, for example, often bredfor high CBD content and have minimal levels of THC (less than 0.3%).Examples of topical, transdermal and/or pharmaceutically effectivecannabinoids include CBD (for example, full spectrum hemp oil).Cannabinoid, including, for example, phytocannabinoids including CBD,can be in an amount of about 0.1 wt % to about 10 wt %, 0.1 wt % toabout 1 wt %, about 0.5 wt % to about 6 wt %, about 2 wt %, about 2.1 wt%, about 4 wt %. CBD can be in an amount of 0.1 wt % to about 10 wt %,about 0.5 wt % to about 5 wt %, about 0.5 wt % to about 2 wt % %, about2 wt %, about 2.1 wt %, about 4 wt %. Full spectrum CBD or hemp oil canbe in an amount of about 0.1 wt % to about 10 wt %, 0.1 wt % to about 1wt %, about 0.5 wt % to about 6 wt %, about 2 wt %, about 2.1 wt %,about 4 wt %. Unit dosage formulations of the embodiments of the presentdisclosure can include cannabinoid, for example, a phytocannabinoid(including for example, CBD) in the amount of about 2 mg. to about 195mg., about 14 mg. to about 100 mg., about 14 mg. to about 80 mg., about70 mg. to about 195 mg., about 10 mg. to about 15 mg, about 70 mg. toabout 80 mg, about 1900 mg. to about 195 mg, about 14 mg, about 77 mg,about 193 mg. Unit dosage formulations of the embodiments of the presentdisclosure can include CBD in the amount of about 2 mg. to about 195mg., about 14 mg. to about 100 mg., about 14 mg. to about 80 mg., about70 mg. to about 195 mg., about 10 mg. to about 15 mg, about 70 mg. toabout 80 mg, about 1900 mg. to about 195 mg, about 14 mg, about 77 mg,about 193 mg. Unit doses of full spectrum hemp oil can include an amountof about 2 mg. to about 195 mg., about 14 mg. to about 100 mg., about 14mg. to about 80 mg., about 70 mg. to about 195 mg., about 10 mg. toabout 15 mg, about 70 mg. to about 80 mg, about 1900 mg. to about 195mg, about 14 mg, about 77 mg, about 193 mg. Unit dosage formulations ofthe embodiments of the present disclosure can include cannabinoid, forexample, a phytocannabinoid (including for example, CBD) or fullspectrum hemp oil in the amount of about 5 mg./ml. to about 40 mg./ml.,about 5 mg./ml. to about 20 mg./ml., about 9 mg. to about 16 mg./ml.,about 9 mg./ml., about 15 mg./ml. Unit dosage formulations of theembodiments of the present disclosure can include CBD in the amount ofabout 1 mg./ml. to about 50 mg./ml, about 5 mg./ml. to about 40 mg./ml.,about 5 mg./ml. to about 20 mg./ml., about 9 mg./ml to about 16 mg./ml.,about 9 mg./ml., about 15 mg./ml. Unit dosage formulations of theembodiments of the present disclosure can include full spectrum CBD oilin an amount of about 5 mg./ml. to about 40 mg./ml., about 5 mg./ml. toabout 20 mg./ml., about 9 mg./ml to about 16 mg./ml., about 9 mg./ml.,about 15 mg./ml.

Unit dosage formulations of the embodiments of the present disclosurecan include cannabinoid, for example, a phytocannabinoid (including forexample, CBD) in the amount per unit of surface area (e.g., surfaceareas 102 and 104 in FIG. 1, in FIG. 2A with surface areas 202 and 204and in FIG. 2B and with surface areas 208 and 210) of about 0.1 mg./cm²to about 2 mg./cm², about 0.5 mg./cm² to about 1 mg./cm², about 0.5mg./cm² to about 0.6 mg./cm², about 0.5 mg./cm², about 0.53 mg./cm²,about 0.5 mg./cm², about 1 mg./cm². Unit dosage formulations of theembodiments of the present disclosure can include CBD in the amount ofabout 0.1 mg./cm² to about 2 mg./cm², about 0.5 mg./cm² to about 1mg./cm², about 0.5 mg./cm² to about 0.6 mg./cm², about 0.5 mg./cm²,about 0.53 mg./cm², about 0.5 mg./cm², about 1 mg./cm². Unit dosageformulations of the embodiments of the present disclosure can includefull spectrum CBD oil in an amount of about 0.1 mg./cm² to about 2mg./cm², about 0.5 mg./cm² to about 1 mg./cm², about 0.5 mg./cm² toabout 0.6 mg./cm², about 0.5 mg./cm², about 0.53 mg./cm², about 0.5mg./cm², about 1 mg./cm². An effective amount of cannabinoid includes ananalgesic, pain relieving, pain treating or anti-inflammatory amount ofcannabinoid.

Cannabinoids, for example, CBD can have a local and/or a systemic effectand may reduce pain imparting and regulating the endocannabinoid(neurotransmitter of the nervous system) receptor activity. Thesubsequent body functions that may be regulated include pain, sleep,appetite and immune system response (through, at least, in part, byreducing inflammation).

For the purpose of the present disclosure, the word “cannabinoid” refersto one or more cannabinoids or cannabinoid compounds or oils or extractsfrom plants (for example, hemp including hemp oil and full spectrum CBDor full spectrum hemp oil) that include one or a plurality ofphytocannabinoids.

Full spectrum hemp oil is oil derived from the entire plant except theflower (which contains THC) and can have over 85 phytocannabinoids whichcan have a positive synergistic effect as compared to compositionshaving fewer cannabinoids. There may also be benefits to othercomponents of it (e.g., terpenes). Such benefits and effect may includefaster penetration and/or permeation of the therapeutic componentsthereof. Full spectrum hemp oil can include full spectrum hemp oil thathas been purified to include less than the below stated amounts of oneor more of the following impurities:

Aflatoxins B1, 82, G1, G2 (fats, oils, lecithin, egg powder): <0.1 mg/kgof each of Aflatoxin B1, Aflatoxin B2, Aflatoxin G1 and Aflatoxin G2,Sum of all positive Aflatoxins <0.4 mg/kg.

GlyphosatelAMPAiGlufosinate: <0.1 mg/kg of each of Glufosinate,Glyphosate and Aminomethylphosphonic acid (AMPA)

Mercury: <0.02 mg/kg

Arsentic: <0.03 mg/kg

Cadmium: <0.01 mg/kg

Lead: <0.05 mg/kg.

Menthol is an active agent and an organic compound that can be madesynthetically or obtained from mint oils such as corn mint andpeppermint. Medicinally, it been found that menthol can have anesthetic(e.g., local) by, for example, blocking nerve signal transmission) andcounterirritant properties as well as anti-inflammatory properties(e.g., systemic and local) as well as a cooling effect when administeredtopically to a patient. Furthermore, menthol is a vasodilator that canaccelerate the transport of active in the circulatory system. Ingeneral, the action of local anesthetics can restrict to the site ofapplication and rapidly reverses upon diffusion from the site of actionin the nerve. Local anesthetics can also serve an important function inproviding peripheral pain relief. Topical administration ofpain-relieving anesthetics can provide important advantages oversystemic or local, non-topical administration. Menthol can be in anamount of about 1 wt % to about 10 wt %, about 5 wt % to about 10 wt %,about 5 wt %, about 6 wt %, about 8 wt %. Unit dosage formulations ofthe embodiments of the present disclosure can include menthol in theamount of about 2 mg. to about 400 mg., about 30 mg. to about 40 mg.,about 210 mg. to about 220 mg., about 380 mg. to about 390 mg., about 36mg., about 217 mg., about 386 mg. Unit dosage formulations of theembodiments of the present disclosure can include menthol in the amountof about 1 mg./ml. to about 40 mg./ml, about 10 mg./ml. to about 35mg./ml., about 20 mg./ml. to about 30 mg./ml., about 23 mg./ml to about27 mg./ml., about 26 mg./ml to about 30 mg./ml., about 23 mg./ml., about26 mg./ml, about 30 mg./ml. Unit dosage formulations of the embodimentsof the present disclosure can include menthol in the amount per unit ofsurface area (e.g., surface areas 102 and 104 in FIG. 1, in FIG. 2A withsurface areas 202 and 204 and in FIG. 2B and with surface areas 208 and210) of about 0.1 mg./cm² to about 3 mg./cm², about 1 mg./cm² to about 2mg./cm², about 1.3 mg./cm² to about 1.6 mg./cm², about 1.33 mg./cm²,about 1.55 mg./cm², about 2 about 1.33 mg./cm². An effective amount ofmenthol includes an anesthetic, pain reducing (e.g., analgesic) oranti-inflammatory effective amount of menthol.

Menthol may be stabilized using methods know in the art, such as, forexample, mixing it with about 0.1 wt % to about 10 wt %, about 0.5 wt %to about 5 wt % of a surfactant including edible nonionic surfactantsand ionic surfactants, such as, for example, sucrose fatty acid ester,polysorbate (e.g., polysorbate 80), hydrogenated castor oil (e.g.,polyoxyethylene hydrogenated castor oil), cocamidopropyl betaine, etc.

The aspects of the present disclosure also relate to hydrogels, forexample, a hydrous hydrogel, for the delivery of, for example,pharmaceutical compositions, including analgesic pharmaceuticalcompositions, that contain a pharmaceutically effective amount of apharmaceutically acceptable and effective cannabinoid and apharmaceutically effective amount of menthol and topical compositions,including topical analgesic compositions, that contain apharmaceutically topical effective amount of a topically acceptable andeffective cannabinoid and a pharmaceutically topical effective amount ofmenthol.

An embodiment of the present disclosure relates to a hydrous hydrogelcomprising an aqueous base, a biocompatible polymer, a polyalcohol, apharmaceutically and/or topically effective amount of a pharmaceuticallyand topically acceptable and effective cannabinoid, for example, aphytocannabinoid or full spectrum CDB or hemp oil, and apharmaceutically and/or topically effective amount of a pharmaceuticallyand topically acceptable and effective menthol.

Another embodiment of the present disclosure relates to a hydroushydrogel analgesic composition comprising an aqueous base, abiocompatible polymer, a polyalcohol, a pain reducing (e.g., analgesicand/or anesthetic) and/or anti-inflammatory pharmaceutically andtopically effective amount of a pharmaceutically and topicallyacceptable and effective cannabinoid, for example, a phytocannabinoid orfull spectrum CDB or hemp oil, and a pain reducing (e.g., analgesicand/or anesthetic) and/or anti-inflammatory pharmaceutically andtopically effective amount of a pharmaceutically and topicallyacceptable and effective menthol.

Another embodiment of the present disclosure relates to a hydroushydrogel composition comprising an aqueous base, a pharmaceuticallyacceptable biocompatible polymer, a pharmaceutically acceptablepolyalcohol, a pain reducing (e.g., analgesic and/or anesthetic) and/oranti-inflammatory pharmaceutically and topically effective amount of apharmaceutically and topically acceptable and effective cannabinoid, forexample, a phytocannabinoid, and a pain reducing (e.g., analgesic and/oranesthetic) and/or anti-inflammatory pharmaceutically and topicallyeffective amount of a pharmaceutically and topically acceptable andeffective menthol.

Another embodiment of the present disclosure relates to a hydroushydrogel analgesic and/or anti-inflammatory composition comprising anaqueous base, a pharmaceutically and topically pharmaceuticallyacceptable biocompatible polymer, a pharmaceutically and topicallyacceptable polyalcohol, a pain reducing (e.g., analgesic and/oranesthetic) and/or anti-inflammatory pharmaceutically and topicallyeffective amount of a pharmaceutically and topically acceptable andeffective cannabinoid, for example, a phytocannabinoid or full spectrumCDB or hemp oil, and a pain reducing (e.g., analgesic and/or anesthetic)and/or anti-inflammatory pharmaceutically and topically effective amountof a pharmaceutically and topically acceptable and effective menthol.

The aqueous base can be, for example, water. Water should be deionizedand pharmaceutically acceptable free of impurities and microbiologicalorganisms that could harm the user. Total water content (includingresidual water present in other ingredients) can be in an amount ofabout 70 wt % to about 95 wt %, about 80 wt % to about 95 wt %, about 82wt % to about 92 wt %, about 83 wt % to about 91 wt %, about 83 wt %,about 87 wt %, about 91 wt %.

Suitable biocompatible polymers that act as gelling, thickening and/orstabilizing agents can include for example of, includingpharmaceutically acceptable biocompatible polymers, can include gelatin,agar, sodium carboxymethylcellulose, pectin, sodium alginate,sodium/calcium alginate, polylactic acid, chitosan, carageenan, xanthan,gellan, polyaspartic acid, polyglutamic acid, hyaluronic acid or saltsor derivatives thereof. A preferred biocompatible polymer is carageenan.Biocompatible polymer, such as, for example, carrageenan, including iotacarrageenan, can be in an amount of about 0.5 wt % to about 10 wt %,about 0.5 wt % to about 1 wt %, about 0.75 wt % to about 1 wt %, about0.75 wt %. Some of the biocompatible polymers may also stabilize thementhol component of embodiments of the present disclosure.

Suitable polyalcohols that can act as a humectant to, for example,stabilize oil in water compositions and retain water, includepharmaceutically acceptable biocompatible polyalcohols, can includealcohols containing 2 to 10 carbon atoms and 2 to 7 hydroxyl groupsincluding, for example, ethylene glycol, 1,2-propylene glycol,1,4-butylene glycol, glycerine, glycerine betaine, erythrit(meso-1,2,3,4-Butantetrol), sorbit, mannit, methylglucoside,diglycerine, triglycerine and/or pentaerythrit as well as sodiumlactate. Polyalcohols, such as for example, glycerin can be in an amountof about 1 wt % to about 25 wt %, about 1 wt % to about 4 wt %, about 2wt % to about 3 wt %, about 3 wt %.

An embodiment of the present disclosure relates to a hydrogelcomposition comprising an aqueous base, glycerin, carageenan, apharmaceutically effective amount of a pharmaceutically and/or topicallyacceptable and effective cannabinoid, for example, a phytocannabinoid orfull spectrum CDB or hemp oil, and a pharmaceutically and/or topicallyacceptable effective amount of a pharmaceutically acceptable andeffective menthol.

Another embodiment of the present disclosure relates to a hydrogelanalgesic composition comprising an aqueous base, glycerin, carageenan,a pain reducing (e.g., analgesic and/or anesthetic) and/oranti-inflammatory pharmaceutically and/or topically effective amount ofa pain reducing (e.g., analgesic and/or anesthetic) and/oranti-inflammatory pharmaceutically and/or topically acceptable andeffective cannabinoid, for example, a phytocannabinoid, and a painreducing (e.g., analgesic and/or anesthetic) and/or anti-inflammatorypharmaceutically and/or topically effective amount of a pain reducing(e.g., analgesic and/or anesthetic and/or anesthetic) and/oranti-inflammatory pharmaceutically and/or topically acceptable andeffective menthol.

In a one embodiment of the present disclosure, the hydrogel comprises anaqueous base (including water) in an amount of 70 wt % to about 95 wt %,about 80 wt % to about 95 wt %, about 82 wt % to about 92 wt %, about 83wt % to about 91 wt %, about 83 wt %, about 87 wt %, about 91 wt %, thebiocompatible polymer (including carageenan) in an amount of about 0.5wt % to about 5 wt %, about 0.5 wt % to about 1 wt %, about 0.75 wt % toabout 1 wt %, about 0.75 wt %, the polyalcohol (including glycerine) inan amount of about 1 wt % to about 5 wt %, about 1 wt % to about 4 wt %,about 2 wt % to about 3 wt %, about 3 wt %; cannabinoid, for example,phytocannabinoids of full spectrum CBD or hemp oil, in an amount ofabout 0.1 wt % to about 10 wt %, 0.1 wt % to about 1 wt %, about 0.5 wt% to about 6 wt %, about 2 wt %, about 2.1 wt %, about 4 wt %. includingunit dosage amounts of about 2 mg. to about 195 mg., about 14 mg. toabout 100 mg., about 14 mg. to about 80 mg., about 70 mg. to about 195mg., about 10 mg. to about 15 mg, about 70 mg. to about 80 mg, about1900 mg. to about 195 mg, about 14 mg, about 77 mg, about 193 mg, about5 mg./ml. to about 40 mg./ml., about 5 mg./ml. to about 20 mg./ml.,about 9 mg. to about 16 mg./ml., about 9 mg./ml., about 15 mg./ml; andmenthol in an amount of about 1 wt % to about 10 wt %, about 5 wt % toabout 10 wt %, about 5 wt %, about 6 wt %, about 8 wt % including unitdosage amounts of 2 mg. to about 400 mg., about 30 mg. to about 40 mg.,about 210 mg. to about 220 mg., about 380 mg. to about 390 mg., about 36mg., about 217 mg., about 386 mg, about 1 mg./ml. to about 40 mg./ml,about 10 mg./ml. to about 35 mg./ml., about 20 mg./ml. to about 30mg./ml., about 23 mg./ml to about 27 mg./ml., about 26 mg./ml to about30 mg./ml., about 23 mg./ml., about 26 mg./ml, about 30 mg./ml.

In another embodiment of the present disclosure, the hydrogel compriseswater in an amount of 70 wt % to about 95 wt %, about 80 wt % to about95 wt %, about 82 wt % to about 92 wt %, about 83 wt % to about 91 wt %,about 83 wt %, about 87 wt %, about 91 wt %, carageenan in an amount ofabout 0.5 wt % to about 5 wt %, about 0.5 wt % to about 1 wt %, about0.75 wt % to about 1 wt %, about 0.75 wt %; glycerin in an amount ofabout 1 wt % to about 5 wt %, about 1 wt % to about 4 wt %, about 2 wt %to about 3 wt %, about 3 wt %; cannabinoid, for example,phytocannabinoids and full spectrum CBD or hemp oil, in an amount ofabout 0.1 wt % to about 10 wt %, 0.1 wt % to about 1 wt %, about 0.5 wt% to about 6 wt %, about 2 wt %, about 2.1 wt %, about 4 wt %. Fullspectrum hemp oil can be in an amount of 0.1 wt % to about 10 wt %,about 0.5 wt % to about 5 wt %, about 0.5 wt % to about 2 wt % %, about2 wt %, about 2.1 wt %, about 4 wt % including unit dosage amounts ofabout 2 mg. to about 195 mg., about 14 mg. to about 100 mg., about 14mg. to about 80 mg., about 70 mg. to about 195 mg., about 10 mg. toabout 15 mg, about 70 mg. to about 80 mg, about 1900 mg. to about 195mg, about 14 mg, about 77 mg, about 193 mg, about 5 mg./ml. to about 40mg./ml., about 5 mg./ml. to about 20 mg./ml., about 9 mg. to about 16mg./ml., about 9 mg./ml., about 15 mg./ml; and menthol in an amount ofabout 1 wt % to about 10 wt %, about 5 wt % to about 10 wt %, about 5 wt%, about 6 wt %, about 8 wt % including unit dosage amounts of 2 mg. toabout 400 mg., about 30 mg. to about 40 mg., about 210 mg. to about 220mg., about 380 mg. to about 390 mg., about 36 mg., about 217 mg., about386 mg, about 1 mg./ml. to about 40 mg./ml, about 10 mg./ml. to about 35mg./ml., about 20 mg./ml. to about 30 mg./ml., about 23 mg./ml to about27 mg./ml., about 26 mg./ml to about 30 mg./ml., about 23 mg./ml., about26 mg./ml, about 30 mg./ml.

The terms “treating” and “effective amount”, as used herein, unlessotherwise indicated, means reversing, alleviating, inhibiting theprogress of, or preventing the disorder or condition to which such termapplies, or one or more symptoms of such disorder or condition. The term“treatment”, as used herein, unless otherwise indicated, refers to theact of treating as “treating” is defined immediately above. The term“treating” also includes adjuvant and neo-adjuvant treatment of asubject.

In a further embodiment, a kit is disclosed. One example of such a kitis a kit including a composition or unit dose composition (e.g., a patchor mass of embodiment composition) of one of the embodiments of thepresent disclosure including multiple unit doses and instructions foruse.

Optional ingredients include skin oil cleanser and/or cooling agentssuch as, for example, denatured alcohol or isopropyl alcohol.

Skin oil cleanser and/or cooling agents, including pharmaceuticallyacceptable skin oil cleanser and/or cooling agents, can include, forexample, alcohols such as denatured alcohol or isopropyl alcohol. Onepurpose of such a skin oil cleanser and/or cooling agents would be tobreak-up oil deposits on the skin where the composition is applied wheresuch deposits may interfere with the transdermal passage of thecannabinoid and menthol ingredients into the tissue beneath the skinlayer. Skin oil cleanser and/or cooling agents, such as, for example,denatured alcohol can be generally used at levels of from about 0.1 wt %to about 2 wt %, about 0.5 wt % to about 1.5 wt %, about 1 wt % to about2 wt %, about 1 wt %.

In a one embodiment of the present disclosure, the hydrogel comprises anaqueous base (including water) in an amount of 70 wt % to about 95 wt %,about 80 wt % to about 95 wt %, about 82 wt % to about 92 wt %, about 83wt % to about 91 wt %, about 83 wt %, about 87 wt %, about 91 wt %, thebiocompatible polymer (including carageenan) in an amount of about 0.5wt % to about 5 wt %, about 0.5 wt % to about 1 wt %, about 0.75 wt % toabout 1 wt %, about 0.75 wt %, the polyalcohol (including glycerine) inan amount of about 1 wt % to about 5 wt %, about 1 wt % to about 4 wt %,about 2 wt % to about 3 wt %, about 3 wt %; cannabinoid, for example,phytocannabinoids and full spectrum CBD or hemp oil, in an amount ofabout 0.1 wt % to about 10 wt %, 0.1 wt % to about 1 wt %, about 0.5 wt% to about 6 wt %, about 2 wt %, about 2.1 wt %, about 4 wt %. CBD canbe in an amount of 0.1 wt % to about 10 wt %, about 0.5 wt % to about 5wt %, about 0.5 wt % to about 2 wt % %, about 2 wt %, about 2.1 wt %,about 4 wt % including unit dosage amounts of about 2 mg. to about 195mg., about 14 mg. to about 100 mg., about 14 mg. to about 80 mg., about70 mg. to about 195 mg., about 10 mg. to about 15 mg, about 70 mg. toabout 80 mg, about 1900 mg. to about 195 mg, about 14 mg, about 77 mg,about 193 mg, about 5 mg./ml. to about 40 mg./ml., about 5 mg./ml. toabout 20 mg./ml., about 9 mg. to about 16 mg./ml., about 9 mg./ml.,about 15 mg./ml; menthol in an amount of about 1 wt % to about 10 wt %,about 5 wt % to about 10 wt %, about 5 wt %, about 6 wt %, about 8 wt %including unit dosage amounts of 2 mg. to about 400 mg., about 30 mg. toabout 40 mg., about 210 mg. to about 220 mg., about 380 mg. to about 390mg., about 36 mg., about 217 mg., about 386 mg, about 1 mg./ml. to about40 mg./ml, about 10 mg./ml. to about 35 mg./ml., about 20 mg./ml. toabout 30 mg./ml., about 23 mg./ml to about 27 mg./ml., about 26 mg./mlto about 30 mg./ml., about 23 mg./ml., about 26 mg./ml, about 30 mg./ml;and a skin oil cleanser and/or cooling agent (including denaturedalcohol) in an amount of about 0.1 wt % to about 2 wt %, about 1 wt % toabout 2 wt %, about 1 wt %.

In another embodiment of the present disclosure, the hydrogel comprisesabout 3.0 wt % glycerin; about 91 wt % water; about 1.0 wt % denaturedalcohol; about 5 wt % menthol (about 36.33 mg; about 23 mg./ml.); andabout 2.0 wt % full spectrum CBD or hemp oil (about 14.53 mg; about 9.2mg./ml.).

In another embodiment of the present disclosure, the hydrogel comprisesabout 3.0 wt % glycerin; about 87 wt % water; about 1.0 wt % denaturedalcohol; about 6 wt % menthol (about 217 mg; about 26 mg./ml); and about2.0 wt % full spectrum CBD or hemp oil (about 77 mg; about 9.4 mg./ml.).

In another embodiment of the present disclosure, the hydrogel comprisesabout 3.0 wt % glycerin; about 83 wt % water; about 1.0 wt % denaturedalcohol; about 8 wt % menthol (about 386 mg; about 30 mg./ml.); andabout 4.0 wt % full spectrum CBD or hemp oil (about 193 mg; about 15mg./ml.).

All of the embodiments included here are with the proviso that the sumof ingredients in the exemplary compositions does not exceed 100%.

Embodiments of the present disclosure may be delivered for local orsystemic administration to a body part of a person to be treated withthe embodiment, for example, a body or skin surface by placing anembodiment of the present disclosure on a body part or skin surfacethereof in active agent-transmitting relation thereto, the active agentsbeing cannabinoid, for example, phytocannabinoid or full spectrum CDB orhemp oil, and menthol. Alternatively, an embodiment of the presentdisclosure may be incorporated into a delivery system, such as a unitdose delivery system (e.g. a “patch.”). In manufacturing such systems,the hydrogel adhesive composition may be cast or extruded onto a backinglayer or release liner and the surface from which the backing layer orrelease liner was removed can serve as the skin-contacting face of thesystem and act as an active agent reservoir. Alternatively, the hydrogelcomposition may be used as an active agent reservoir within the interiorof such a system, with a conventional skin or other body part contactadhesive laminated thereto to affix the system to a body part or skinsurface thereof. In such embodiments including a reservoir, thecannabinoid, for example, CBD or full spectrum CDB or hemp oil, could bein the reservoir and the menthol in the hydrogel housing the reservoir.

Other embodiments of the present disclosure include a method ofrelieving pain and/or inflammation by topically administering and placedtopically to a body part (e.g., arm, leg, knee, torso, head, neck, footas well as those parts that make-up them), of a mammal (e.g., a humanpatient or veterinary patient) in need of such treatment at least one ofthe compositions disclosed herein. Still other embodiments of thepresent disclosure include a method of relieving bodily pain (localand/or systemic) by topically administering to placed topically on abody part (e.g., arm, leg, knee, torso, head, neck, foot as well asthose parts that make-up them), of a mammal (e.g., a human patient orveterinary patient) in need of such treatment at least one of thecompositions disclosed herein. Still other embodiments of the presentdisclosure include a method of relieving pain and/or inflammation (localand/or systemic) by administering to a body part, for example, placedtopically on an arm, leg, knee, torso, head, neck, foot as well as thoseparts that make-up them, of a mammal (e.g., a human patient orveterinary patient) in need of such treatment at least one of thecompositions disclosed herein. Still other embodiments of the presentdisclosure include a method of relieving bodily pain and/or inflammation(local and/or systemic) by topically administering to placed topicallyon a body part (e.g., arm, leg, knee, torso, head, neck, foot as well asthose parts that make-up them), of a mammal (e.g., a human patient orveterinary patient) in need of such treatment at least one of thecompositions disclosed herein by placing the composition topically on abody part (e.g., arm, leg, knee, torso, head, neck, foot as well asthose parts that make-up them).

For embodiments that are placed on a body part (e.g., patchembodiments), the dosing time can range from about 30 minutes to about12 hours, about 30 minutes to about 8 hours (based on in vitro testing),30 minutes to about 2 hours or about 30 minutes to about 1 hour. Thegreater the amount of glycerin, the longer the maximum the therapeuticdosing time The remainder can then be removed from the body part or skinsurface thereof.

Another embodiment of the present disclosure relates to a compositioncontaining particles which have a core containing an active agent or asalt thereof coated with a barrier layer. The barrier layer is formedfrom a coating liquid that contains a least one water insoluble barrierforming component selected from a group consisting of ethyl cellulose,copolymers of acrylic and methacrylic esters and natural or syntheticwaxes, and a plasticizer.

The amount of the active agent administered may be dependent on thesubject being treated, the severity of the disorder or condition, therate of administration, the disposition of the compound and thediscretion of the prescribing physician. However, an effective dosage isin the range of about 0.001 to about 100 mg. per kg body weight per day,preferably about 1 to about 35 mg./kg/day, in single or divided doses.For a 70 kg human, this would amount to about 0.05 to about 7 g/day,preferably about 0.1 to about 2.5 g/day. In some instances, dosagelevels below the lower limit of the aforesaid range may be more thanadequate, while in other cases still larger doses may be employedwithout causing any harmful side effect, provided that such larger dosesare first divided into several small doses for administration throughoutthe day.

Any standard manufacturing procedure known in the art may be used tomanufacture the hydrous hydrogels of the present disclosure. Forexample, in a vessel (with or without mixing), at a temperature above70° C., one could add in order, water, the biocompatible polymer (e.g.,carrageenan), the polyalcohol (e.g., glycerin), a surfactant (e.g.,polysorbate 80), the menthol and the CBD ingredient. The mixture fromthe vessel is cast or spread into a hydrogel film and passed through atrefrigerated tunnel at about 30° C. to about 50° C. or colder. Thecolder the refrigerated tunnel, the less water that is evaporated orlost from the hydrogel film. The hydrogel film can then be cut ordivided into various forms and sizes e.g., the embodiments of thepresent disclosure. After it is cut or divided, the hydrogel can beplaced in its packaging and sprayed with the skin oil cleanser and/orcooling agent (e.g., denatured alcohol or isopropyl alcohol) to coat itsexterior surface including surface areas shown in the figures of thepresent disclosure, immediately before sealing the package, for example,the package embodiment of the present disclosure.

The embodiments of the present disclosure (including hydrogel masses andpatches) can be extruded directly onto a substrate such as a backinglayer or release liner, and then pressed.

Systems for the topical or transdermal administration of an active agentmay comprise: a reservoir containing a therapeutically effective amountof an active agent; an adhesive means for maintaining the system inactive agent transmitting relationship to a body surface; and a backinglayer as described above, wherein a disposable release liner covers theotherwise exposed surface, protecting such surface during storage andprior to such surface being applied topically (also as described above).

The compositions, patch or device of the present disclosure will containa quantity of an active agent effective to provide the desired dosage oreffect over a predetermined delivery period. The compositions, patch ordevice of the present disclosure include the hydrogel compositions aswell as masses thereof including patches and other shapes that can betopically applied topically to a body part or portion thereof.

The compositions of the present disclosure may also include arate-controlling membrane on the body surface side of the drugreservoir. The materials used to form such a membrane are selected tolimit the flux of one or more components contained in the drugformulation, and the membrane may be either microporous or dense.Representative materials useful for forming rate-controlling membranesinclude polyolefins such as polyethylene and polypropylene, polyamides,polyesters, ethylene-ethacrylate copolymer, ethylene-vinyl acetatecopolymer, ethylene-vinyl methylacetate copolymer, ethylene-vinylethylacetate copolymer, ethylene-vinyl propylacetate copolymer,polyisoprene, polyacrylonitrile, ethylene-propylene copolymer,polysiloxane-polycarbonate block copolymer and the like.

An example of such a kit is a sealed water-proof package containing anembodiment of the present disclosure. Another aspect of the presentdisclosure is a water-proof package designed to contain of thecomposition or patch embodiments of the present disclosure and to keep asubstantial amount of the moisture (i.e., water) in the embodiment. Onepackage embodiment is illustrated in FIGS. 4A and 4B and can includefoil enclosure 400 with side sections 402 and 404 that are sealedtogether along a common peripheral edge 406. Inside the enclosure 400 isan internal void in which a patch 408 is positioned.

Example 1

Size of unit dose patch: 6.5 cm×4.2 cm (27.3 cm²) with thickness from0.0508 cm to 0.06604 cm. volume about 1.58 ml, total weight 762.62 mg.Ingredients: glycerin 3.0 wt % (21.8 mg.); water base material 91 wt %(661.22 mg.); denatured alcohol 1.0 wt % (7.27 mg.); menthol 5 wt %(36.33 mg; 23 mg./ml.); and full spectrum hemp oil 2.0 wt % (14.53 mg;9.2 mg./ml.).

Example 2

Size of unit dose patch: 10 cm×14 cm (140 cm²) with thickness from0.0508 cm to 0.06604 cm. volume about 8.176 ml, total weight 3633 mg.Ingredients: glycerin 3.0 wt % (108 mg.); water base material 87.21 wt %(3168 mg.); denatured alcohol 1.0 wt % (36 mg.); menthol 6 wt % (217 mg;26.5 mg./ml.); and full spectrum hemp oil 2.10 wt % (77 mg; 9.4mg./ml.).

Example 3

Size of unit dose patch: 12 cm×16 cm (192 cm²) with thickness from0.0508 cm to 0.06604 cm. volume about 12.68 ml, total weight 4830 mg.Ingredients: glycerin 3.0 wt % (145 mg.); water base material 83.25 wt %(4021 mg.); denatured alcohol 1.0 wt % (48.3 mg.); menthol 8 wt % (386.4mg; 30.4 mg./ml.); and full spectrum hemp oil 4.0 wt % (193.2 mg; 15.2mg./ml.).

All publications, including but not limited to, issued patents, patentapplications, and journal articles, cited in this application are eachherein incorporated by reference in their entirety.

Thus, while there have been shown, described and pointed out,fundamental novel features of the present disclosure as applied to theexemplary embodiments thereof, it will be understood that variousomissions and substitutions and changes in the form and details ofdevices and methods illustrated, and in their operation, may be made bythose skilled in the art without departing from the spirit or scope ofthe present disclosure. Moreover, it is expressly intended that allcombinations of those elements and/or method steps, which performsubstantially the same function in substantially the same way to achievethe same results, are within the scope of the present disclosure.Moreover, it should be recognized that structures and/or elements and/ormethod steps shown and/or described in connection with any disclosedform or embodiment of the present disclosure may be incorporated in anyother disclosed or described or suggested form or embodiment as ageneral matter of design choice. It is the intention, therefore, to belimited only as indicated by the scope of the claims appended hereto.

This written description uses examples as part of the disclosure,including the best mode, and also to enable any person skilled in theart to practice the disclosed implementations, including making andusing any devices or systems and performing any incorporated methods.The patentable scope is defined by the claims, and may include otherexamples that occur to those skilled in the art. Such other examples areintended to be within the scope of the claims if they have structuralelements that do not differ from the literal language of the claims, orif they include equivalent structural elements with insubstantialdifferences from the literal languages of the claims.

While there have been shown, described and pointed out, fundamentalfeatures of the present disclosure as applied to the exemplaryembodiments thereof, it will be understood that various omissions andsubstitutions and changes in the form and details of compositions,devices and methods illustrated, and in their operation, may be made bythose skilled in the art without departing from the spirit or scope ofthe present disclosure. Moreover, it is expressly intended that allcombinations of those elements and/or method steps, which performsubstantially the same function in substantially the same way to achievethe same results, are within the scope of the present disclosure.Moreover, it should be recognized that structures and/or elements and/ormethod steps shown and/or described in connection with any disclosedform or embodiment of the present disclosure may be incorporated in anyother disclosed or described or suggested form or embodiment as ageneral matter of design choice. It is the intention, therefore, to belimited only as indicated by the scope of the claims appended hereto.

The invention claimed is:
 1. A transdermal analgesic hydrogel patch fortopical application to the skin of a mammal, the transdermal analgesichydrogel patch comprising: water in an amount of from about 70 wt % toabout 95 wt %; carageenan in an amount of from about 0.5 wt % to about 5wt %; glycerin in an amount of from about 1 wt % to about 5 wt %; fullspectrum hemp oil in an amount of from about 0.1 wt % to about 10 wt %;and menthol in an amount of from about 1 wt % to about 10 wt % in theamount per unit of surface area of from about 0.1 mg./cm² to about 3mg./cm², wherein the composition includes less than 0.3% THC, thepercentage amounts are all based on the total weight of the patch andthe full spectrum hemp oil is purified to include the below statedamounts of one or more of the following impurities: less than 0.1 μg/kgof each of Aflatoxins BI, 82, G1, G2 and the sum of all positiveAflatoxins is less than 0.4 μg/kg; less than 0.1 mg/kg of each ofGlufosinate, Glyphosate and Aminomethylphosphonic acid (AMPA); less than0.02 mg/kg of mercury; less than 0.03 mg/kg of arsenic; less than 0.01mg/kg of cadmium; and less than 0.05 mg/kg of lead.
 2. The transdermalanalgesic hydrogel patch of claim 1, further including a skin oilcleanser in an amount of from about 0.1 wt % to about 2 wt %.
 3. Thetransdermal analgesic hydrogel patch of claim 2, wherein the skin oilcleanser includes denatured alcohol.
 4. The transdermal analgesichydrogel patch of claim 1, wherein the patch is a unit dose formulationand includes full spectrum hemp oil in a unit dose amount per volume ofthe patch of from about 5 mg./ml. to about 40 mg./ml. and menthol in aunit dose amount per volume of the patch of from about 1 mg./ml. toabout 40 mg./ml.
 5. A method of treating pain or inflammation in a bodypart or portion thereof of a mammal using a transdermal hydrogel patch,the transdermal hydrogel patch including a unit dose formulationcomprising: water in an amount of from about 70 wt % to about 95 wt %;carageenan in an amount of from about 0.5 wt % to about 5 wt %; glycerinin an amount of from about 1 wt % to about 5 wt %; full spectrum hempoil in a unit dose amount of from about 2 mg. to about 195 mg; andmenthol in a unit dose amount of from about 2 mg. to about 400 mg.; anda skin oil cleanser including denatured alcohol, wherein the compositionincludes less than 0.3% THC and the percentage amounts are all based onthe total weight of the patch and the full spectrum hemp oil is purifiedto include the below stated amounts of one or more of the followingimpurities: less than 0.1 pg/kg of each of Aflatoxins BI, 82, G1, G2 andthe sum of all positive Aflatoxins is less than 0.4 pg/kg; less than 0.1mg/kg of each of Glufosinate, Glyphosate and Aminomethylphosphonic acid(AMPA); less than 0.02 mg/kg of mercury; less than 0.03 mg/kg ofarsenic; less than 0.01 mg/kg of cadmium; and less than 0.05 mg/kg oflead, the method comprising: topically applying the transdermal hydrogelpatch to a skin surface of the body part of the mammal; breaking up oildeposits on the skin surface to which the transdermal hydrogel patch isapplied using the skin oil cleanser where the oil deposits interferewith the transdermal passage of the full spectrum hemp oil and mentholinto tissue beneath the skin surface; and delivering the full spectrumhemp oil and menthol through the skin surface to which the transdermalhydrogel patch is applied and into the tissue beneath the skin surface.6. The method of claim 5, wherein the full spectrum hemp oil is in anamount of from about 0.1 wt % to about 10 wt %.
 7. The method of claim5, wherein menthol is in an amount of menthol from about 1 wt % to about10 wt %.
 8. The method of claim 5, wherein the skin oil cleanser is inan amount of from about 0.1 wt % to about 2 wt %.
 9. The method of claim5, further including topically administering the transdermal hydrogelpatch for a minimum of about 30 minutes.
 10. The method of claim 5,wherein the pain or inflammation being treated is at least one of localpain or inflammation and systemic pain or inflammation.